Bathing Additives in Pediatric Atopic Dermatitis

Not Applicable

Terminated

• Conditions: Dermatitis, Atopic
• Interventions: Other: Bathing Additive

• Registration Number: NCT02582788
• Lead Sponsor: Mayo Clinic

Brief Summary

The current clinical guidelines for management of atopic dermatitis now recommend bleach baths. This requires simply the addition of regular household bleach to twice-weekly baths. At the Mayo Clinic, dilute acetic acid (vinegar) has been recommended for decades in wet wraps to treat patients hospitalized for their atopic dermatitis. However, this practice has not been widely adopted in the pediatric dermatology community. Will the use of dilute acetic acid (vinegar) in twice weekly baths help manage atopic dermatitis in pediatric patients as well as, or better than, the current accepted guidelines?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-21
• Study Start: 2015-10
• Study First Submitted QC: 2015-10-19
• Study First Posted: 2015-10-21
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Patients from 6 months to 17 years of age

2. Currently residing in US.

3. Follow up visits at 1 month, 3 months and 6 months after initiation of treatment in study (Figure 1).

4. Last follow-up at 1 year in clinic or via written mailed-out survey.

5. Diagnosis of atopic dermatitis AND

   1. Have active signs of bacterial skin infection OR
   2. Any documented suspected history of bacterial skin infection (weeping, crusting, and/or pustules on exam), OR
   3. Prescription for oral antibiotics for skin infection in the past 6 months from any provider). OR
   4. Have been prescribed bleach baths as part of an atopic dermatitis skin care regimen.

Exclusion Criteria

1. Superficial skin infection without diagnosis of atopic dermatitis
2. Lack of in-clinic follow up assessment at 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bleach	Bathing Additive	Patients will use bleach added to their baths twice a week.
Vinegar	Bathing Additive	Patients will use vinegar (dilute acetic acid) added to their baths twice a week.

Primary Outcome Measures

Name	Time	Method
EASI score at 6 months	6 months

Secondary Outcome Measures

Name	Time	Method
Courses of antibiotics required	1 year

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States